# K091268: Hospira Latex-Free Critical Care and Advanced Sensor Catheters

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Sep 18, 2009 after 141 days
- Product code: DQE (Catheter, Oximeter, Fiber-Optic)
- Device class: 2
- Regulation: 21 CFR 870.1230
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K821057 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061450: Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters, Hospira, Inc. (2006) Summary page 1.

## Recalls of this device
- Jan 2, 2020 · Class II · Z-1999-2020: Inability for the guidewire to pass through the needles included with the catheter kits.
- Jan 2, 2020 · Class II · Z-1997-2020: Inability for the guidewire to pass through the needles included with the catheter kits.
- Jan 2, 2020 · Class II · Z-2001-2020: Inability for the guidewire to pass through the needles included with the catheter kits.
- Jan 2, 2020 · Class II · Z-2000-2020: Inability for the guidewire to pass through the needles included with the catheter kits.
- Jan 2, 2020 · Class II · Z-1998-2020: Inability for the guidewire to pass through the needles included with the catheter kits.

## Indications for use
Hospira Advanced Sensor Catheters: Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions. Hospira Critical Care Catheters: Indicated for the assessment of hemodynamic status through right atrial, right ventricular,, and pulmonary artery and/or wedge, pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation;' diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling. Additional indication for Hospira Critical Care Pacing Lead Catheters: Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

Source page: https://510kreport.com/device/K091268
Methodology: https://510kreport.com/methodology